Biotechs focused on cell and gene therapies need support beyond the traditional outsourcing of development and manufacturing to CDMOs. These elongated “support chains” start within the healthcare system, run cells out to a CDMO for processing, and then circle back to the patient. Jason Gardner, co-founder, CEO and president of Magenta Therapeutics, believes he’s found a partner to help.
A diverse group of industry veterans discuss ways in which the FDA encourages innovation, what role the agency’s Emerging Technology Team (ETT) plays in supporting manufacturing innovation, and whether the regulator’s innovation-safety balance is (or should be) the same for rare or orphan disease treatments as it is for blockbuster drugs.
Consultants play a significant role in the pharmaceutical, biopharmaceutical, vaccine, and medical device industries. They are experienced resources in crisis situations; when new facilities are being installed; under circumstances requiring technical expertise; and during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants, and both contribute to them. Motivational enablers/drivers increase the probability that a project will be completed successfully, provided the consultant acquires their own motivational abilities coupled with experience that meets the project requirements.
The November 2017 decision by CMS to change the coding practice for biosimilars in the United States is likely to have far-reaching consequences for these drugs, but will all downstream effects be positive? As the decision is applauded by various prescriber, patient, and industry groups, it is key to investigate the events that could ensue from the decision, and whether it will stimulate the U.S. biosimilar industry, which languishes behind that of other geographies.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
Due to a paradigm shift in the pharmaceutical industry, there is rising pressure to come up with faster, more cost-effective ways to produce drugs for the patients who need them.
Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.
A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility.
Based out of South Boston, MA, with additional research programs in the UK and Canada, Vertex Pharmaceuticals has spent the past 25 years working to improve the lives of patients with serious diseases.
Dry powder inhaler (DPI) devices that utilize two-piece capsules as the dose-holding system can require specialized dosing equipment to fill the capsules. Such products are known as "premetered."
This application note describes the performance of single-use Xcellerex XDM Quad Mixing System used as a slurry tank when packing chromatography columns. The capability of the mixing system to keep the chromatography medium (resin) in suspension and the possibility to integrate the system in column packing were studied. The results show that XDM Quad Mixing System is suitable for use as a media slurry tank when packing chromatography columns.
Biosimilars are considered to be one of the fastest growing sectors of the pharmaceutical industry.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Design of Experiments (DoE) mathematical models can help create the perfect environment for batch and fed batch cultures. Understanding the different criteria and their interactions with each other can be a key differentiator in the race to get your drug to market.
When selecting a bioreactor, you can choose stainless steel or single-use technologies, depending on your biomanufacturing requirements. The bioreactor is a key component of your bioprocessing workflow and should be regarded as a strategic asset. It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.
In order to ensure a smooth development and clinical process, companies must carefully plan their activities with regard to the innovator biopharmaceutical.
Molecules continue to get more challenging from the perspective of solubility, bioavailability, and exposure. Advances in formulation technologies continue to provide more solutions. Establishing effective communications between DS chemists and DP formulators manage the risks and maximize the rewards of transforming less soluble and less bioavailable molecules into effective new drugs.
A larger scale adoption of SUT may continue to be delayed as biopharmaceutical manufacturers must have access to a reliable supply chain that allows us to successfully deliver product to our customers.